ClinicalTrials.gg
RecruitingNCT04963426Updated Aug 7, 2024

Empowering Adolescents to Lead Change Using Health Data

An interventional study of Behavioral interventions targeting multiple risk behaviors as well as protective factors and School-level interventions targeting the school environment and system in Healthy, sponsored by World Health Organization. Recruiting at 5 sites in 5 countries. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-08-07.

Sponsored by World Health Organization · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Jul 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Jan 2022; still recruiting 4 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
12,612
Allocation
Randomized
Ages
13 Years to 17 Years
Sex
All
01

Study summary

This study is a cluster randomized trial carried out in schools of secondary cities of four low- and middle income countries. Baseline surveys in 30 randomly selected schools will assess the health behaviours of 13-17 year old students as well as school policies and practices. The intervention arm (15 schools) will use the baseline information to develop a package of actions in collaboration with students, teachers, and local authorities that will subsequently be implemented an monitored over two years. Follow-up surveys to evaluate the effectiveness of the implemented actions will be conducted after two years in all 30 previously selected schools.

Read the detailed description

The objective of this study is to generate health information through school surveys and use this information directly and locally, involving adolescents, to change policies and plan programmes to improve health.

The study is carried out in secondary cities of four low- and middle income countries, including Sekondi-Takoradi, Ghana; Jaipur, India; Spanish Town, Jamaica; and Fez, Morocco.

In each of the four cities, 30 schools are randomly selected. Baseline surveys will be conducted to assess (1) 13-17 year old student's health behaviours using the Global School-based Student Health Survey (GSHS); and (2) health policies and practices in the selected schools using the Global School Health Policies and Practices Study (G-SHPPS). Additionally, the physical activity module of the GSHS questionnaire will be validated against objective measurement devices in one randomly selected class of 15 randomly selected schools.

Schools will be randomly allocated to the intervention (15 schools) or control arm (15 schools) of the study. The intervention group will participate in interactive workshops using the Global Accelerated Action for the Health of Adolescents (Global AA-HA!) approach and the framework of Making every school a health-promoting school to:

  1. Identify adolescent health needs through exploring the collected data;
  2. Assess policies and practices already in place;
  3. Identify gaps and needs for action to improve health. Students, teachers and local authorities will propose and prioritize policy and programme solutions from menus of effective interventions for school-, community- or city-level implementation, supported by the Ministries of Health and Education and WHO.

Repeat GSHS and G-SHPPS surveys will be conducted two years later in all schools to assess effectiveness of the interventions.

02

Conditions studied

  • Healthy

Keywords

  • adolescent health
  • students
  • schools
  • risk factors
  • protective factors
  • school health services
03

In context

Lead sponsor

World Health Organization is the lead sponsor of 10 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • School going
  • Aged 13-17 years

Exclusion criteria

Exclusion Criteria:

  • Not going to school
  • Outside the age range 13-17 years
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
12,612 participants (estimated)

Study arms

  • Experimental
    Intervention arm

    The intervention consists of interactive workshops that will be facilitated by WHO and trained local personnel and involve students, teachers and local authorities. In the workshops, the Global Accelerated Action for the Health of Adolescents (Global AA-HA!) approach will be used to: * identify adolescent health needs through exploring the collected baseline data; * assess policies and practices already in place; * identify gaps and needs for action to improve health. A menu of actions will be identified, prioritized, implemented and monitored.

    Behavioral: Behavioral interventions targeting multiple risk behaviors as well as protective factors · Other: School-level interventions targeting the school environment and system

  • No intervention
    Control arm

    The schools in the control arm will not participate in any intervention and continue 'as usual' after the baseline surveys.

Interventions

  • BehavioralBehavioral interventions targeting multiple risk behaviors as well as protective factors

    Depending on the baseline data and prioritization of actions, behavioral interventions related to the following topics will be implemented: alcohol use, dietary behaviors, drug use, hygiene, mental health, physical activity, protective factors, sexual behaviors, tobacco use, violence and unintentional injury.

  • OtherSchool-level interventions targeting the school environment and system

    Depending on the baseline data and prioritization of actions, and based on the Global Standards for Health Promoting Schools, school-level interventions related to the following will be implemented: school policies and resources, school governance and leadership, school and community partnerships, school curriculum, school social-emotional environment, school physical environment, school health services

06

What researchers measure

Primary outcomes

  1. Alcohol use

    Self-reported alcohol use measured with the Global School-based Student Health Survey (GSHS)

    Time frame: Two years

  2. Dietary behaviors

    Self-reported dietary behaviors measured with the Global School-based Student Health Survey (GSHS)

    Time frame: Two years

  3. Drug use

    Self-reported drug use measured with the Global School-based Student Health Survey (GSHS)

    Time frame: Two years

  4. Hygiene

    Self-reported hygiene measured with the Global School-based Student Health Survey (GSHS)

    Time frame: Two years

  5. Mental health

    Self-reported mental health measured with the Global School-based Student Health Survey (GSHS)

    Time frame: Two years

  6. Physical activity

    Self-reported physical activity measured with the Global School-based Student Health Survey (GSHS)

    Time frame: Two years

  7. Protective factors

    Self-reported protective factors measured with the Global School-based Student Health Survey (GSHS)

    Time frame: Two years

  8. Sexual behaviors

    Self-reported sexual behaviors measured with the Global School-based Student Health Survey (GSHS)

    Time frame: Two years

  9. Tobacco use

    Self-reported tobacco use measured with the Global School-based Student Health Survey (GSHS)

    Time frame: Two years

  10. Violence and unintentional injury

    Self-reported violence and unintentional injury measured with the Global School-based Student Health Survey (GSHS)

    Time frame: Two years

Other outcomes

  1. School-level policies and practices

    School-level outcomes related to the following: school policies and resources, school governance and leadership, school and community partnerships, school curriculum, school social-emotional environment, school physical environment, school health services measured with the Global School Health Policies and Practices Study (G-SHPPS)

    Time frame: Two years

07

Study locations

5 of 5 sites recruiting
  • WHO
    Sekondi-Takoradi, Ghana
    Enrolling by invitation
  • WHO
    Jaipur, India
    Enrolling by invitation
  • WHO
    Spanish Town, Jamaica
    Recruiting
    • Uki Atkinson · Contactuatkinson@ncda.org.jm
    • Uki Atkinson · Principal investigator
    • Dolores Ondarsuhu · Sub investigator
    • Sonja Caffe · Sub investigator
    • Roberta De Betania Caixeta · Sub investigator
  • WHO
    Fez, Morocco
    Recruiting
    • Tahar Ouaourir · Contacto_tahar2011@yahoo.fr
    • Tahar Ouaourir · Principal investigator
    • Hafid Hachri · Sub investigator
    • Heba Fouad · Sub investigator
    • Khalid Siddeeg · Sub investigator
  • WHO
    Geneva, 1211, Switzerland
    Enrolling by invitation
08

References and documents

Individual participant data

Plan to share: Yes — After a two year window following completion of data collection, the GSHS and G-SHPPS data will be released as public access datasets, including in the WHO NCD microdata repository.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: The documents above will become available after the study protocol has been published in a scientific journal.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2022 (actual). Primary completion is estimated for Jul 2026, 54 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 5, 2021
First posted
Jul 15, 2021
StartActual
Jan 1, 2022
Primary completionEst.
Jul 2026
CompletionEst.
Jan 2027
Last update
Aug 7, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04963426
Lead sponsor
World Health Organization
Collaborators
Fondation Botnar, University of Bern, University of Wollongong
Responsible party
Regina Guthold (Scientist, World Health Organization) — Principal investigator
First posted
Jul 15, 2021
Start date
Jan 1, 2022
Primary completion
Jul 2026 (estimated)
Completion
Jan 2027 (estimated)
Last update
Aug 7, 2024

Study contacts

Regina Guthold, PhD
Contact
gutholdr@who.int
+41 79 621 5691
Leanne M Riley, MSc
Contact
rileyl@who.int
+41 22 791 4319
Regina Guthold, PhD
principal investigator · World Health Organization

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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